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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03117868
Other study ID # RNI2016-04
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2, 2016
Est. completion date November 28, 2017

Study information

Verified date July 2020
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Fractures of the upper femur (EFSF) represent a major public health problem in the elderly. Approximately 1.6 million patients are victims each year of an EFSF and this number is increasing as a result of the aging of the population.

In a recent Amiens retrospective study the mortality was estimated to be 22.5% at 1 year of the fracture. In surviving patients, the impact on loss of autonomy and degradation of quality of life is considerable.

The reduction of the incidence of post-operative complications includes the identification of risk factors.

No prospective study in Amiens has investigated the mortality and the study of the variables involved in the prognosis and long-term mortality of these patients.


Recruitment information / eligibility

Status Completed
Enrollment 310
Est. completion date November 28, 2017
Est. primary completion date November 28, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All the patients operated from a fracture of traumatic origin of the ESF to the emergency block at the CHU of Amiens

- Patients transferred to the CHU after being cared for in another structure will be included.

- If a patient successively presents a fracture of each upper extremity of the femur outside of a surgical resumption, two inclusions will be realized

Exclusion Criteria:

- Do not include non-traumatic fractures of the upper end of the femur (pathological fractures: cancer, for example)

- Fractures of the upper end of the femur associated with polytrauma will not be included.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Study of mortality at 6 months
The objective is to provide strong arguments for establishing a dynamic of collective care for patients suffering from an EFSF

Locations

Country Name City State
France CHU Amiens Picardie Amiens Picardie

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality at 6 months of EFSF patients 6 months
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